Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
FDA Recall Z-0124-2020 · Posted None
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusOpen, Classified
Product CodeGWM
Date Initiated2019-09-12
Product Quantity189
Reason for Recall
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Firm Action
On 9/12/19, the customers were notified by a visit from the Sales Representative who delivered a notification letter at that time. The letter, URGENT: VOLUNTARY MEDICAL DEVICE RECALL, dated 9/12/19, included the following instructions:
1. If you have a CereLink ICP monitor, Model #826820, discontinue using the product as soon as clinically possible and remove the product from service.
2. Your sales representative will facilitate the return of your monitor.
3. Complete the information on the Acknowledgement Form attached to this letter and either provide it to your sales representative or email or fax as indicated on the form. Keep a copy of the form for your records.
Should you have any questions regarding these instructions, please contact Customer Service
Monday to Friday 8:00 AM 8:00 PM EST
USA: 1-800-654-2873: email: [email protected]
Outside USA: 781-565-1401
Root Cause
Under Investigation by firm
Distribution Pattern
The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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